Modella AI gets FDA breakthrough device designation for generative AI copilot

PathChat 2a (research use only) is capable of patch, slide, and case level reasoning.
PathChat 2a (research use only) is capable of patch, slide, and case level reasoning.
Business Wire

Modella AI has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA) for its generative artificial intelligence (AI) copilot, PathChat DX.

According to a statement from Modella AI, PathChat DX is an extension of the PathChat model developed by a team led by Faisal Mahmood, PhD, at Mass General Brigham; PathChat was outlined in an article in Nature in June 2024.

PathChat was designed to employ generative AI and multimodal analysis to assist pathologists in diagnosing complex cases with greater accuracy and efficiency, Modella AI said. The tool uses a combination of pathology foundation models trained on histology image and image-text datasets and a custom-trained multimodal large language model to analyze high-resolution pathology images and clinical data.

PathChat DX is currently undergoing additional testing and evaluation to ensure that it meets regulatory standards and clinical safety requirements, Modella AI added.


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